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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name parathyroid autofluorescence imaging device
De Novo Number DEN170092
Device Name Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Requester
fluoptics
7 parvis louis neel
cs 20050
grenoble cedex 9,  FR 38040
Contact odelie allard
Regulation Number878.4550
Classification Product Code
QDG  
Date Received12/22/2017
Decision Date 11/02/2018
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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